Reported Dec 9, 2020 · Terminated
CAS-930A Flat Panel Monitor (FPD) used in conjunction with the Canon Interventional Angiography System, Model numbers:…
Canon Medical System, USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Canon Medical System, USA, INC. · 2441 Michelle Dr · Tustin, CA · 92780-7047
Is this the product you have?
- CAS-930A Flat Panel Monitor (FPD) used in conjunction with the Canon Interventional Angiography System
- Model numbersInfinix-8000C
- and Infinix-8000H - Product UsageThis device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities
- Lot codes and dates
- Affected Serial Numbers
1 AFA16620012 AFB18720053 AFB18320034 AFB18720045 AFB18920066 BFA18Y70017 AEA17X20018 AFA16920029 AEB181200210 BFA193200111 BFB195200312 BFB194200213 BFB197200414 BFB197200515 AFB189200716 BEC203200117 BFC206200718 BFC206200819 BHA199200120 BFC2012006
- Affected Serial Numbers
- Amount recalled
- 14 units
Where it was sold
Why it was recalled
There is a potential that the cable of the Flat panel detector may break during a procedure which may cause the x-ray device to stop before the examination is completed. This could result in a delay with procedure and/or potential damage to the patients blood vessels due to removal without visibility.
This product could cause temporary or reversible health problems — stop using it.
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